510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070859Substantially Equivalent

Reprocessed Ethicon Ets Endoscopic Linear Cutters

Sterilmed Inc, Maple Grove MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070859 is the FDA 510(k) clearance record for REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS, a class II device, cleared for Sterilmed, Inc. on under FDA product code NLL (Staple, Implantable, Reprocessed). FDA's definition for product code NLL reads: "Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)". FDA records list 65 510(k) clearances for Sterilmed, Inc., from to . As of , FDA records show no recalls naming K070859.

Clearance record

Decision date
Received
(168 days to decision)
Product code
NLL Staple, Implantable, Reprocessed
Regulation
21 CFR 878.4750
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Sterilmed, Inc. 11400 73rd Ave. N, Maple Grove MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NLL

Trailing 12 months

FDA records hold no clearances under product code NLL in the trailing twelve months.

FDA records show no clearances under product code NLL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NLL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260